About this course
Although 21 CFR Part 111 does not contain any specific sections that address risk assessment or risk management, risk management is an integral part of any business and is a critical component for a successful dietary supplement business. Being able to access and manage risk is critical to how a company’s policies, procedures and processes are developed and implemented. From vendor and material selection to cleaning processes and evaluating QC lab test results, risk management principles are essential to making good decisions that not only protect the quality and safety of products, but also ensure a successful business. Whether you are a contract manufacture or simply a marketer of finished products, a good risk management program based on sound principles is essential for long-term success in the industry.
Who Should Attend
The training is designed for QA/QC managers, R&D managers and personnel, product developers, analytical method developers and laboratory personnel, quality system auditors and staff, and regulatory personnel.
Course outline
What You Will Learn
- What risk management is and why is it important?
- Risk assessment tools and principles including: hazard identification, dose response analysis, exposure quantification
- How to evaluate internal risks versus external risks
- Understand the roles of risk assessment versus risk management
- The importance of using CAPA and good documentation in risk management
- How to apply risk management to various areas of your business including
- change control
- quality processes
- ingredient selection
- vendor selection & auditing
- quality testing
- facility design
- equipment selection
- HACCP plans and allergen control
Discussion and Working Groups
A significant proportion of the course time will be devoted to group work, where delegates have the opportunity, through case studies, to put theory into practice.
Additionally, discussion periods will provide delegates with plenty of time to obtain answers to their specific questions and concerns.
Venue
Salt Lake City, UT - Marriott City Center
Salt Lake City Marriott City Center
220 South State Street · Salt Lake City, Utah 84111 USA
1-801-961-8700
- Walk to Temple Square, shopping & dining from this AAA 4-diamond Salt Lake City hotel
- Named as one of the best Salt Lake City hotels for quality and service
- Free high-speed Internet access, award-winning service, 15,000 sq ft of event space
Tutors
We believe that our team of experts are the best available. Not only have they got years of experience in the industry, but they are committed to tutoring and helping those inside the industry to improve and raise the standards. We understand that you attend courses to learn about the latest regulations and to get your questions answered.
Our expert for this course is:
What you've said
“NLI is always working to implement the most stringent quality systems and looking for opportunities to prove the superiority of its systems. DSQP certification with NSF-DBA has been another way for NLI to show a commitment to being a CMO of the highest quality. Investment in training ensures your company is in compliance and manufacturing safe products for the public”
Jera’le Smith, Director of Quality Assurance, Nutritional Laboratories International (NLI)
“I attended both NSF-DBA’s FDA inspection Readiness and Corrective Action Management modules and our company assiduously implemented the recommendations made. I am absolutely convinced that doing so was one of the primary reasons our company did not receive an FDA Form 483 following an FDA unannounced 4-day GMP inspection”
Kim Randall Pearson, General Counsel, Thorne Research, Inc.
An NSF International Company